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NCT04330729Recruiting

The Effect of Salicylate on Platelet Function in CKD (Chronic Kidney Disease) Patients Treated With Aranesp

The Effect of Low-dose Salicylate Treatment on Platelet Function in Patients With Renal Failure Treated With Darbepoetin Alfa

Source: ClinicalTrials.gov · Last updated 25 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The aim of the study is to 1. To determine whether treatment with Erythropoiesis-stimulating agents (in the form of Aranesp®) affects platelet function, and how. 2. To determine whether salicylate treatment changes the effect of EPO (erythropoietin) on platelet function.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
20 Mar 2020
Start date
15 Apr 2020
Primary completion date
31 Dec 2026
Lead sponsor
Zealand University Hospital
NCT number
NCT04330729

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 15 Apr 2020 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known indication for ASA. If the patient is being treated with ASA, and the physician does not find any indication for this treatment, this can be stopped, and the patient included after 4 weeks.
  • Current anticoagulant therapy, e.g. warfarin, ADP receptor inhibitor (excepting short-term anticoagulant therapy in connection with dialysis)
  • Change in ESA dosis \>33,3% within previous 2 month

Other illness

  • Known allergy to ASA
  • Known contraindication to ASA, e.g. recent bleeding episode.
  • Active cancer - except for non-melanoma skin-cancer

Lab values

  • Raised reticulocyte count

Age

  • Fertile women. Pregnancy is excessively rare in dialysis patients. Women who are \<50 years, or who are still menstruating will be excluded from the study.

Other

  • Short expected length of life
  • Inability to give informed consent
  • Expected non-compliance
  • Iron deficiency (defined as a reticulocyte Hgb \<1,8 fmol. Patients can be included when their iron deficiency has been cured. .
  • Stable Aranesp ® dose \<20 µg/week.

Who the study is looking for

  • Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively
  • aged 18-85
  • indication for treatment with Erythropoiesis-stimulating agents (ESA)

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medicinsk afdeling, SUH Roskilde
Coordinator of this site? Confirm its status
RoskildeDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.